NCT00941135终止2 期
Phase II Study of TPF Induction Chemotherapy Followed by Hyperfractionated Radiotherapy With Cetuximab "Boost Concomitant" With Cetuximab in Patients With Local Advanced Larynx/Hypolarynx Carcinoma
Fundacion Miguel Servet8 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2009年5月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 70
- 试验地点
- 8
- 主要终点
- To evaluate progression-free time in patients with complete or partial response >30% evaluated over primary tumour(T and N) after TPF induction treated with RT + Cetuximab.
研究概览
简要总结
To evaluate the progression free time in patients with completed or partial response > 30% evaluated over primary tumour (damage T and N) after induction TPF (Docetaxel, Cisplatin, 5-FU) treated with RT + Cetuximab over 2 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient informed consent must be signed before to start the study.
- •Age between 18 to 70 years.
- •Performance Status 0-1 according to ECOG scale at the moment of inclusion.
- •Life expectancy >3 months.
- •Confirmed anatomopathologic diagnosis of local advance scaly larynx or hypolarynx carcinoma III or IV stage without evidence of distance metastasis, which surgery involve a total laryngectomy.
- •T3, T4A, T4B or T2 not candidate to a partial laryngectomy. In case of T2 of both locations it will be required III or IVA stage.
- •Patients in medical conditions to receive neoadjuvant treatment with TPF followed by hyperfractionated radiotherapy combined with cetuximab.
- •Presence of a injury measurable with RECIST criteria.
- •Neutrophils > or = 1500/mm3, platelets > or = 150.000/mm3 and haemoglobin > or =10 g/dL.
- •Renal Function appropriate
- •Hepatic Function appropriate
- •Serum Calcium tight to albumine < or = 1,25 x upper normal limit (UNL).
- •Nutritional status appropriate: weight loss < 20% and albumine > or = 35 g/L.
- •Women of childbearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation.
排除标准
- •Metastatic disease.
- •Surgical treatment, radiotherapy and/or previous chemotherapy.
- •Another tumour locations in head and neck area different from larynx or hypo larynx.
- •Another stages different from III or IVa without distant metastasis and resectable disease.
- •Another previous scaly carcinoma
- •Diagnosis of another neoplasia in last 5 years, except cervix carcinoma in situ and/or basocellular cutaneous carcinoma adequately treated.
- •Active infection treated by ATB IV, including active tuberculosis and VIH.
- •Hypertension not controled defined as systolic > or = 180 mm Hg and/or diastolic > or =130 mm Hg at rest.
- •Pregnant/lactating women.
- •Systemic immune treatment, chronic and concomitant, or cancer hormone treatment.
- •Another antineoplastics concomitant treatments.
- •Coronary artery disease or history of heart attack in the last 12 months or high risk of arrythmia uncontrolled or cardiac insufficiency uncontrolled.
- •EPOC that required more than 3 hospitalizations in the last 12 months.
- •Active ulcus not controled.
- •Psychiatric illness/social situations that would limit compliance with study requirements
- •Drug abuse (except alcohol abuse)
- •Knowledge of Allergic to study treatment.
- •Previous treatment with Monoclonal antibodies.
- •Any experimental treatment in the previous 30 days to start the study.
结局指标
主要结局
To evaluate progression-free time in patients with complete or partial response >30% evaluated over primary tumour(T and N) after TPF induction treated with RT + Cetuximab.
时间窗: 2 years
次要结局
未报告次要终点
研究者
研究点 (8)
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